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Clinical Trial NCT05986370 (METRIC) for Chronic Low-back Pain is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The METRIC Study Protocol 112
Clinical Trial NCT05986370 (METRIC) is an interventional study for Chronic Low-back Pain that is recruiting. It started on 25 October 2023 with plans to enroll 112 participants. Led by Université du Québec à Trois-Rivières, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 4 December 2023.
Brief Summary
The goal of this clinical trial is to test the effects of spinal manipulative therapy in individuals with chronic primary low back pain and determine the neurophysiological mechanisms underlying pain relief. The main questions it aims to answer are: • Is pain relief produced by spinal manipulative therapy in patients with chronic primary low back pain caused by a reduction of C-fiber-related nociceptive processing? •...Show More
Official Title
The METRIC Study Protocol: an Explanatory Randomized Controlled Trial Investigating the Neurophysiological Mechanisms Underlying the Therapeutic Effects of Spinal Manipulative Therapy for Chronic Primary Low Back Pain
Conditions
Chronic Low-back PainPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- METRIC
NCT ID Number
Start Date (Actual)
2023-10-25
Last Update Posted
2023-12-04
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
112
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
chronic primary low back pain
spinal manipulative therapy
nociplastic pain
central sensitization
C-fibers
brain
electroencephalography
spinal manipulative therapy
nociplastic pain
central sensitization
C-fibers
brain
electroencephalography
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentallumbar spinal manipulative therapy Participants will receive spinal manipulative therapy (SMT) exclusively at dysfunctional lumbar segments. Participants will receive 36 SMT sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform two spinal manipulations, one on each side of the most painful lumbar vertebra. During s...Show More | lumbar spinal manipulative therapy Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops). |
Experimentalfull spine spinal manipulative therapy Participants will receive spinal manipulative therapy (SMT) at dysfunctional spinal segments in the lumbar AND other spine regions. Participants will receive 36 spinal manipulative therapy (SMT) sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform a minimum of two spinal manipula...Show More | full spine spinal manipulative therapy Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops). |
Sham Comparatorsham spinal manipulative therapy Participants will receive 36 sham SMT sessions (3x/week for 12 weeks, each session ≈15 min). This will target dysfunctional segments in the lumbar and other spine regions. Three maneuvers will be used:
* Ventral decubitus: 1 to 5 light and brief manual contacts (≈ 20 N and 5 s) will be applied and quickly released over the spinous process of dysfunctional vertebrae identified during clinical examination.
* Dorsal de...Show More | sham spinal manipulative therapy Sham spinal manipulative therapy (sham SMT), was designed to be structurally equivalent to SMT, i.e., to attend to the same body regions with the same amount of contact as well as to have the same number, frequency and length of sessions. SMT and sham SMT will be provided by the same treatment provider and will appear to be similarly tailored to the participants' condition. Sham SMT does not share the component of in...Show More |
No Interventionno intervention This fourth arm will comprise healthy volunteers (age/sex-matched to the participants in the test intervention - lumbar group) who will not receive any intervention. The main purpose of this fourth group is to provide reference values to interpret some results obtained in participants with chronic primary low back pain. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
low back pain intensity | In accordance with recommendations for chronic pain trials, participants will be instructed to rate the intensity of their LBP using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). As in the brief pain inventory (BPI), they will be instructed to rate their pain: 1) right now; 2) on average over the last 7 days; 3) at its worst over the last 7 days; 4) at its best over the last 7 days. | baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization. |
temporal summation of second pain | Participants will receive a total of 160 painful laser stimuli, 80 single-pulse stimuli and 80 pulse trains (3 pulses delivered at 0.67 Hz). After each stimulus, participants will be prompted to rate second pain with the display of a numerical pain rating scale. The pain ratings of single pulses will be subtracted from the pain ratings of pulse trains to estimate the intensity of the temporal summation of second pain. | baseline, 4- and 12-weeks post-randomization. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
low back pain frequency and duration | A modified version of the pain frequency-severity-duration scale will be used. Participants will be instructed to answer these 3 questions:
* Is the pain recurrent (it comes in episodes) or continuous (it is always present)?
* How many days in the past week have you had low back pain? (0, 1, 2, 3, 4, 5, 6, 7 days; a higher score means a worse outcome)
* On average, how many hours per day does the pain last? (0; 1-4; 5-8; 9-12; 13-16; 17-20; 21-24 hours; a higher score means a worse outcome) | baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization. |
Pressure pain thresholds (PPTs) | PPT will be measured using a handheld digital algometer (Wagner Pain TestTM FPX, Greenwich, Connecticut, USA) and a standardized protocol. The algometer will be applied perpendicularly to the skin of the first test location and the pressure increased at approximately 50 kPa/s until pain is reported by the participant. This procedure will be repeated three times at the same test location. The PPT will be the average of the values obtained during these 3 trials. The same procedures will be repeated at the two other test locations. PPT will be tested on three different body locations: 1) Over the spinous process of the most painful vertebra between L1 and S1; 2) On the right lower limb in the dermatome corresponding to the level of the most painful vertebra; 3) in the center of the right thenar eminence. | baseline, 4- and 12-weeks post-randomization. |
C-fiber-related brain responses | Electroencephalography (EEG) will be recorded using a 64-channel BrainVision system with active Ag-AgCl electrodes mounted on an actiCAP, according to the International 10-20 system (Brain Products, Gilching, Germany). Electrodes will be nose-referenced, and the ground will be set at FPz. Signals will be sampled at 500 Hz. Eye movements and blinks will be recorded using electrooculography (EOG). Electrode impedance will be kept below 20 kΩ. Closed eyes resting state EEG will be recorded for 5 min prior to laser stimuli for exploratory EEG analyses. EEG activity will be recorded continuously. The outcome of interest from laser-evoked-brain activity is the response evoked by C-fiber activation. Laser-evoked potentials (LEP) and event-related spectral perturbations (ERSP) will be analyzed using validated methods. | baseline, 4- and 12-weeks post-randomization. |
Oswestry Disability Index (ODI) | Self-reported low back pain related disability will be evaluated using the French-Canadian version of the ODI (0-100%; a higher score means a worse outcome). | baseline, 4-, 12-, 26-, 39-, 52- and 64-weeks post-randomization. |
Back performance scale (BPS) | The BPS will be used as a performance based outcome of physical function. It includes five daily activities such as putting socks on or picking something on the floor (see PMID: 12444880 for more details). Each activity is rated from 0 to 3, and the five scores are added up (min = 0, max = 15; a higher score means a worse outcome). | baseline, 4- and 12-weeks post-randomization. |
Five times sit-to-stand test | The five times sit-to-stand test will be used as performance based outcome of physical function. Participant sitting on a supported chair will be instructed to stand and sit again as fast as possible, five times in a row. Time will be measured in seconds. The test will be performed twice and the average time for the two trials will be recorded (a higher score means a worse outcome). | baseline, 4- and 12-weeks post-randomization. |
Depression | Depression levels will be measured using the French-Canadian version of the Beck Depression Inventory (BDI; min = 0, max = 63; a higher score means a worse outcome). | baseline, 4- and 12-weeks post-randomization. |
Anxiety | Anxiety levels will be measured using the French-Canadian version of the State-Trait Anxiety Inventory, version Y (STAI-Y; min = 20, max = 80; a higher score means a worse outcome). | baseline, 4- and 12-weeks post-randomization. |
Pain catastrophizing | The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Pain catastrophizing will be measured with the French-Canadian version of the pain catastrophizing scale (PCS; min = 0, max = 52; a higher score means a worse outcome). | baseline, 4- and 12-weeks post-randomization. |
Kinesiophobia | The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Pain-related fear will be measured with a French adaptation of the Tampa scale for kinesiophobia (TSK; min = 17, max = 68; a higher score means a worse outcome). | baseline, 4- and 12-weeks post-randomization. |
Pain vigilance | The main elements contributing to the pain experience according to the fear avoidance model of pain will be measured. Hypervigilance will be measured with a French adaptation of the pain vigilance and awareness questionnaire (PVAQ; min = 0, max = 80; a higher score means a worse outcome). | baseline, 4- and 12-weeks post-randomization. |
Patient's global impression of change | Participants will be instructed to give their global impression of change on a scale from -100 to 100 (-100 = very much worse, 0 = no change, 100 = very much improved). | After the last treatment session (12-weeks post-randomization) |
Expectations of pain relief | Participants will be instructed to rate their expectations of pain relief after the treatment on a scale from 0 to 100, 0 being "no relief" and 100 being "complete relief". | baseline and 4-weeks post-randomization. |
Contextual factors (healing encounters and attitudes lists (HEAL)) | Contextual factors will be measured using a French adaptation of the healing encounters and attitudes lists (HEAL). | baseline, 4- and 12-weeks post-randomization. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Duration of current low back pain (LBP) episode ≥ 6 months;
- Average LBP intensity during the last 7 days ≥ 3/10;
- (For healthy volunteers only) To be of the same sex and age (± 1 year) as a participant with low back pain.
- Diagnosis of back conditions other than chronic primary LBP e.g., failed back surgery syndrome, spondylosis, spondylolisthesis, spinal stenosis, herniated disc, infection, etc.;
- Presence of pain in another body location that is more severe than the pain in the lower back;
- Presence of a neurological deficit i.e., sensation loss, muscle weakness, decreased deep tendon reflexes;
- Presence of contraindications to spinal manipulative therapy e.g., recent fracture, history of spinal surgery, cauda equina syndrome, inflammatory arthritis, taking anticoagulant medication, active cancer, moderate to severe osteoporosis, abdominal aortic aneurysm;
- Underwent surgery in the last 3 months;
- Pregnancy, ≤ 3 months post-partum or planning to get pregnant in the next 12 months;
- History of spinal manipulative therapy in the past 12 months;
- Scoliosis ≥ 20°;
- BMI ≥ 40;
- Insufficient language skills in French to complete the questionnaires;
- Open or pending litigation for LBP or seeking/receiving disability compensation;
- Diagnosis of an illness affecting the sensorimotor functions e.g., diabetes, multiple sclerosis, amyotrophic lateral sclerosis;
- Diagnosis of mental health disorders (with the exception of anxiety and depression);
- Current drug or alcohol dependence;
- Skin of type I on the Fitzpatrick scale;
- (For healthy volunteers only) Regular use of pain medication or usage in the 48 h prior to data collection;
- (For healthy volunteers only) History of chronic pain;
- (For healthy volunteers only) Acute pain on the days of data collection.
Université du Québec à Trois-RivièresStudy Responsible Party
Mathieu Piché, Principal Investigator, Professor, Université du Québec à Trois-Rivières
Study Central Contact
Contact: Benjamin Provencher, 1-819-376-5011, [email protected]
Contact: Mathieu Piché, 1-819-376-5011, [email protected]
1 Study Locations in 1 Countries
Quebec
Université du Québec à Trois-Rivières, Trois-Rivières, Quebec, G8Z 4M3, Canada
Benjamin Provencher, D.C., M.Sc., Contact, 18196906403, [email protected]
Recruiting